title: Prevention of postoperative recurrence with azathioprine or infliximab in patients with Crohn's disease: an open-label pilot study.
abstract: OBJECTIVE
  Patients with Crohn's disease (CD) often require surgery over their clinical course. However, endoscopic and clinical recurrence of disease appear respectively in up to 80% and 30% of patients after one year. Thus, a prophylactic treatment is needed to reduce the possibility of recurrence. Both azathioprine and infliximab have been demonstrated to be effective, but head to head studies have not been performed so far. Aim of this open-label prospective study was to analyse endoscopic, histological and clinical recurrence after one year of treatment with azathioprine or infliximab as postoperative therapies in CD patients with "high risk" of recurrence.
  
  
  METHODS
  Consecutive CD patients who underwent curative ileocolonic resection were randomized (1:1) to receive infliximab (standard induction and maintenance schedule) or azathioprine (2.5 mg/kg/day) for 1 year. Co-primary endpoints were endoscopic, histological and clinical recurrence after 12 months of therapy.
  
  
  RESULTS
  Twenty-two consecutive CD patients (15 male; median age 32 years, IQR 22-38) were enrolled after curative ileocolonic resection. Eleven patients were treated with infliximab and 11 received azathioprine. Among patients treated with azathioprine, 4/10 (40%) had endoscopic recurrence compared to 1/11 (9%) in the infliximab group (p=0.14). Eight out of 10 (80%) among those who received azathioprine had severe histological activity, whereas 2/11 (18%) in the infliximab group presented histological recurrence (p=0.008). No significant clinical differences were found between the two groups.
  
  
  CONCLUSIONS
  Infliximab was more effective than azathioprine in reducing histological, but not endoscopic and clinical recurrence after curative ileocolonic resection in "high risk" CD patients.
authors.affiliation: IBD Unit, Complesso Integrato Columbus, Catholic University, Rome, Italy. Electronic address: alearmuzzi@yahoo.com.
authors.forename: Alessandro
authors.initials: A
authors.lastname: Armuzzi
authors.forename: Carla
authors.initials: C
authors.lastname: Felice
authors.forename: Alfredo
authors.initials: A
authors.lastname: Papa
authors.forename: Manuela
authors.initials: M
authors.lastname: Marzo
authors.forename: Daniela
authors.initials: D
authors.lastname: Pugliese
authors.forename: Gianluca
authors.initials: G
authors.lastname: Andrisani
authors.forename: Francesco
authors.initials: F
authors.lastname: Federico
authors.forename: Italo
authors.initials: I
authors.lastname: De Vitis
authors.forename: Gian Lodovico
authors.initials: GL
authors.lastname: Rapaccini
authors.forename: Luisa
authors.initials: L
authors.lastname: Guidi
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000627:therapeutic use*; D000911:Antibodies, Monoclonal / Q000627:therapeutic use*; D001379:Azathioprine / Q000627:therapeutic use*; D002097:C-Reactive Protein / Q000378:metabolism; D003082:Colectomy; D003113:Colonoscopy; D003424:Crohn Disease / Q000097:blood / Q000473:pathology / Q000517:prevention & control* / Q000601:surgery; D005260:Female; D006801:Humans; D007082:Ileum / Q000601:surgery; D007166:Immunosuppressive Agents / Q000627:therapeutic use*; D060828:Induction Chemotherapy / Q000379:methods; D000069285:Infliximab; D060046:Maintenance Chemotherapy / Q000379:methods; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D011184:Postoperative Period; D011446:Prospective Studies; D055502:Secondary Prevention; D055815:Young Adult
chemical_list: D000894:Anti-Inflammatory Agents, Non-Steroidal; D000911:Antibodies, Monoclonal; D007166:Immunosuppressive Agents; D002097:C-Reactive Protein; D000069285:Infliximab; D001379:Azathioprine
keywords: Azathioprine; Crohn's disease; Infliximab; Post-operative recurrence